Sanctions Granted Against Valsartan Manufacturer for Discovery Abuses

Out of 44 complaints over how Zhejiang Huahei Pharmaceuticals executives answered deposition questions, the special master determined 25 of them merited sanctions.

The Special Master overseeing discovery disputes between parties involved in valsartan cancer lawsuits has determined the Chinese manufacturer of the contaminated ingredient used in many of the recalled blood pressure pills should be sanctioned for obstructing the deposition process in the litigation.

More than 1,000 product liability lawsuits have been filed on behalf of former users of recalled valsartan pills, which were removed from the market in late 2018 after it was discovered changes to the generic drug manufacturing process caused the pills to be distributed with high levels of N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) and other chemical byproducts known to increase the risk of stomach cancer, liver cancer, esophageal cancer, prostate cancer, pancreatic cancer, and other injuries.

Given common questions of fact and law raised in complaints filed in U.S. District Courts nationwide, the federal litigation has been centralized for pretrial proceedings before U.S. District Judge Robert B. Kugler in the District of New Jersey, as part of a multidistrict litigation (MDL), where a “bellwether” process has been established to prepare a small group of cases for early trial dates, which are designed to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout hundreds of claims.

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Side effects of recalled valsartan may increase the risk of cancer, due to an impurity discovered in certain generic versions of the hypertension drug.

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As part of the pretrial proceedings, a number of executives from defendant Zhejiang Huahei Pharmaceuticals Ltd., a Chinese generic drug maker named as a defendant in many of the lawsuits, were required to undergo depositions to answer questions about its manufacturing processes for valsartan. However, plaintiffs filed a motion for sanctions, claiming that many of the executives failed to adequately answer questions as required by law, either by avoiding answering questions requiring a “yes or no” answer, or by claiming they did not have information they were specifically required to have for those deposition interviews.

Special Master Thomas I. Vanaskie, a retired judge, issued a report (PDF) on December 8, which determined that, out of 44 deposition excerpts plaintiffs indicated merited sanctions, 25 of them “warrant some form of relief.” However, he rejected plaintiffs’ claims that the problems showed a systematic effort to disrupt the discovery process.

“Nevertheless, relief is warranted to compensate Plaintiffs for the additional time required where meritless objections were asserted and where witnesses repeatedly failed to give non-evasive responses to appropriate questions,” Special Master Vanaskie wrote. “Plaintiffs are also entitled to receive responsive, non-evasive deposition testimony on the matters covered in this decision.”

Special Master Vanaskie indicated plaintiffs will be given an opportunity to submit a request for fees and expenses incurred in presenting the motion, and ordered the parties to meet and confer on making ZHP provide witnesses to testify on the specific questions which executives failed to answer appropriately, at ZHP’s expense, by December 21.

Judge Kugler, who is overseeing the valsartan litigation, has called for a series of “bellwether” early test cases to go before juries.

While the outcome of these early test trials will not be binding on other plaintiffs, they will be closely watched by parties involved in the litigation and may have a large influence on potential valsartan cancer settlements, providing a gauge for how juries may respond to certain evidence and testimony likely to be repeated throughout the claims.

1 Comments

  • TheraFebruary 4, 2022 at 1:04 pm

    Feb 4th 2022 My doctor changed me from Losartan to Valsartan. The Valsartan pills smell rotten! My internet search revealed that Valsartan has no aroma and no taste. I looked up FDA recalls and found previous Macleod’s Valsartan lots were recalled, but not this new lot number I have, at least not yet. I talked to my doc about this and he said to take the pills anyway. Has anyone else noticed a rot[Show More]Feb 4th 2022 My doctor changed me from Losartan to Valsartan. The Valsartan pills smell rotten! My internet search revealed that Valsartan has no aroma and no taste. I looked up FDA recalls and found previous Macleod’s Valsartan lots were recalled, but not this new lot number I have, at least not yet. I talked to my doc about this and he said to take the pills anyway. Has anyone else noticed a rotten odor in their Valsartan pills? Or a stink in a recalled Valsartan lot?

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